Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0950-2023

Z-0950-2023 Class II Ongoing

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

FDA device recall Z-0950-2023 was initiated by Siemens Healthcare Diagnostics, Inc. on Dec 7, 2022 and is designated Class II. Reason for recall: Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users… The recall status is ongoing. Affected quantity: 7,543 kits.

Recall Details

Product Type: Devices
Report Date: Jan 18, 2023
Initiation Date: Dec 7, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,543 kits

Product Description

IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KTY2 Siemens Material Number (SMN): 10381648

Reason for Recall

Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

Distribution Pattern

Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bolivia¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil¿¿¿¿¿¿¿¿¿ Bulgaria¿¿¿¿¿¿¿ Canada¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Dominican¿Rep.¿ Ecuador¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Honduras¿¿¿¿¿¿¿ Hong¿Kong¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ India¿¿¿¿¿¿¿¿¿¿ Indonesia¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Iraq¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ KA Kazakhstan¿¿¿¿¿ Kosovo¿¿¿¿¿¿¿¿¿ Kyrgyzstan¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Macedonia¿¿¿¿¿¿ Malaysia¿¿¿¿¿¿¿ Mexico¿¿¿¿¿¿¿¿¿ Morocco¿¿¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Panama¿¿¿¿¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Peru¿¿¿¿¿¿¿¿¿¿¿ Philippines¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Republic¿Korea¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Saudi¿Arabia¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Singapore¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ South¿Africa¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Trinidad,Tobago Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ Turkmenistan¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uruguay¿¿¿¿¿¿¿¿ Uzbekistan¿¿¿¿¿ Vietnam¿¿¿¿¿¿¿¿

Code Information

UDI: 00630414962252 Kit Lots: 431, 432, 433, 434, 435, and 436.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0950-2023
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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